← Back to catalogue

Surgical System Sterile Sleeve, 10 Pack

FDA UDI

Class II (US FDA UDI)

by Mazor Robotics Ltd

Identity

Trade Name
Surgical System Sterile Sleeve, 10 Pack FDA UDI
Generic Name
Patient surgical drape, single-use FDA UDI
Device Name
Surgical System Sterile Sleeve, 10 Pack FDA UDI
Model / Reference
KIT0704-02 FDA UDI
Description
Surgical System Sterile Sleeve, 10 Pack FDA UDI

Identifiers

Primary DI / UDI-DI
07290109181127 FDA UDI
FDA Product Code
OLO FDA UDI
HAW FDA UDI
LLZ FDA UDI
GMDN Term
Patient surgical drape, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
892.2050 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Surgical System Sterile Sleeve, 10 Pack by Mazor Robotics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mazor Robotics Ltd

Sources (1)

  • FDA UDI bf300f36-a473-4b11-8ce2-8723c22c123c 34 fields · synced May 30, 2026